Tuesday, June 28, 2016

In an action reminiscent of the tobacco industry of the 1970's, the Detroit Wayne County Mental Health Authority (DWMHA) has issued one of the most fraudulent claims about the risks of cigarette smoking as I have ever seen.

The DWMHA created a billboard in which it told the public that smoking is no more dangerous than vaping. "E-qually dangerous," the billboard asserts.

The Rest of the Story

There is abundant scientific evidence that vaping, which has caused no
documented chronic disease or death in any identified individual, is
safer than smoking, which kills more than 400,000 people each year,
causes chronic lung disease, cardiovascular disease, and cancer, and
contains more than 10,000 chemicals, of which more than 60 are proven
human carcinogens.

There is no debate in the tobacco control community about this point.
Even Dr. Stan Glantz - a fierce opponent of vaping - acknowledges that
smoking is more hazardous than vaping.

Ironically, while the Detroit Wayne County Mental Health Authority is lying to the public,
the tobacco companies are telling the truth. Each of the major tobacco
companies has acknowledged that smoking its cigarettes is far more
dangerous than vaping.

By informing the public that smoking is no more hazardous than using a
product which contains no tobacco and merely creates an aerosol by
heating propylene glycol, glycerin, nicotine, and flavorings, the
DWMHA is dangerously undermining the public's
appreciation of the severe consequences of cigarette smoking.

The misinformation that the Detroit Wayne County Mental Health Authority is disseminating
is damaging to the public's health. First, it may discourage people from
quitting smoking - people who otherwise would have greatly improved
their health by quitting smoking completely with the help of
e-cigarettes. Second, it may convince ex-smokers who have quit using
electronic cigarettes that they are
just as well off returning to smoking than remaining ex-smokers by
virtue of
those electronic cigarettes.

A study just published in the journal Addiction reported that at least 6.1 million people in the EU have quit smoking using e-cigarettes and another 9.2 million have substantially reduced the amount they smoke. This amazing public health accomplishment would obviously not have occurred had public health authorities in Europe conducted a fraudulent campaign to convince EU citizens that vaping is equally hazardous as smoking.

That this fraudulent statement is being made by a mental health services agency is particularly egregious because persons with mental health and substance abuse disorders have disproportionately high rates of smoking and are especially resistant to traditional methods of smoking cessation. These are people who could benefit the most from the availability of e-cigarettes for smoking cessation. But the DWMHA is actively discouraging them from trying to quit smoking. In fact, the message being sent is that you are better off (or equally well off) continuing to smoke than quitting smoking using e-cigarettes.

It's been close to two decades since we've seen a tobacco industry campaign to severely undermine the public's appreciation of the health hazards of smoking. That campaign is now back. It's just a shame that it is now being orchestrated by health agencies, while the cigarette companies are the ones providing accurate information to the public about the real hazards of smoking. Who ever thought it would come to this?

Monday, June 27, 2016

Last month, I reported that Nicopure Labs, a maker of e-liquids and vaping devices, filed a lawsuit against the FDA challenging its deeming regulations, claiming that they are in violation of the Administrative Procedures Act (APA) and the First Amendment. Today, I report that four more lawsuits have been filed against the agency; all seek an injunction against enforcement of various aspects of the regulations or seek to overturn the regulations in their entirety.

1. Lost Art Liquids, LLC has filed a challenge to the deeming regulations under the APA, the Regulatory Flexibility Act, the First Amendment, and the Fifth Amendment.

As the company explains:

"Lost Art Liquids' Complaint alleges that FDA's
regulation of vapor products is illegal in that it exceeds the very
limited and specific scope of authority Congress granted FDA to regulate
"tobacco products" under the Tobacco Control Act in 2009. "Vapor products are technology products, not tobacco products," said Ryan Thomas,
Lost Art Liquids' Co-Founder and COO. "The legislative history and
factual findings that serve as the predicate to the Tobacco Control Act
make clear that Congress never intended to give FDA authority to
regulate vapor products when it enacted the Tobacco Control Act in 2009.
It was created to regulate products like cigarettes and smokeless
tobacco, not vapor," he continued. "FDA has introduced one of
the most burdensome, misguided and harmful regulations in its history
without adequately sound science, or adhering to required, lawful
procedures. These regulations will harm Lost Art Liquids' business and
customers by eliminating vapor products from the market, forcing
consumers to resort to more harmful products like cigarettes and
cigars," added Thomas."

2. Larry Faircloth, a delegate in the West Virginia House of Representatives, has filed a lawsuit against the FDA, challenging the deeming regulations under the APA, the First Amendment, and the Tenth Amendment.

First, the complaint alleges that FDA's application of the Tobacco Act to all vaping devices and their components goes far beyond the Act's definition of "tobacco products" and is therefore a violation of the APA. For example, "programmable software," "batteries," and "glasses and vials" are deemed to be tobacco products even though they clearly do not meet the Act's definition of a tobacco product (i.e., a product made of tobacco or containing a tobacco-derived component [nicotine]).

Second, the complaint alleges that the FDA's ban on new product introductions after August 8, 2016 is arbitrary and capricious and without a rational basis. The effect of this aspect of the regulation is to prevent the introduction of any new products and the improvement of any existing products, thus harming the public's health both by forcing many vapers to return to smoking and by precluding necessary safety improvements.

Third, the complaint alleges that the FDA failed to conduct a proper cost-benefit analysis, as it failed to quantify the benefits of the regulation and grossly underestimated the costs. For example, the agency estimated that only 750 pre-market tobacco applications would be required, while the truth is that there are single companies that would have to file that many applications alone.

Fourth, the complaint alleges that the regulations violate the First Amendment because they prohibit companies from making truthful and non-misleading statements about their products (such as that e-cigarettes contain no tobacco and produce no smoke or that they contain lower levels of various constituents compared to tobacco cigarettes).

3. A coalition of vaping-related associations, including the Right to Be Smoke-Free Coalition, the American E-Liquid Manufacturing Standards Association, and the American Vaping Association, has challenged the deeming regulations under the APA, the Regulatory Flexibility Act, the First Amendment, the Fifth Amendment, and the Fourteenth Amendment.

Many of the complaints in this lawsuit are similar to those mentioned above, including the allegations that the FDA exceeded its authority, violated the intent of Congress, lacks a rational basis for the regulatory scheme (especially since it treats e-cigarettes more harshly than cigarettes), fails to conduct a proper cost-benefit analysis, and infringes upon the free speech rights of companies by prohibiting them from making truthful, non-misleading claims about their products without any legitimate government interest in doing so. The suit challenges the grandfather date, the entire pre-market authorization process, the ban on allowing customers to try e-liquid flavors in vape shops that are restricted to adults, the application of the "tobacco product" definition to component parts of vaping devices that do not meet that definition, and the entire modified risk provision section.

4. Altria has filed a lawsuit which challenges the deeming regulations' prohibition on the use of the brand name "Black and Mild," which has been the trade name for one of its premium cigar brands for more than four decades.

This suit claims that the ban on the use of the term "mild" in the brand name violates the First Amendment because it restricts free speech without any legitimate government interest and violates the Fifth Amendment because it represents a taking of private property without compensation. Unlike the term "mild" as used in many cigarette brands and ads - which were documented to have been intended to falsely convey a sense of safety - the "Black and Mild" brand name has been around for more than 40 years and conveys information about the taste and body of the product, rather than its safety.

The Rest of the Story

All five of the lawsuits that have been filed so far present strong and solid legal challenges against the deeming regulations. I have been arguing for months that applying the modified risk provisions of the Tobacco Act to e-cigarettes would violate the First Amendment because there is no legitimate government interest in preventing commercial speech that is both truthful and non-misleading. In addition, I pointed out in my comments to OMB/OIRA that the FDA failed to conduct a proper cost-benefit analysis.

Monday, June 20, 2016

Last week, I discussed an article published in Pediatrics which is going to deal a devastating blow to the vaping industry because it wrongly concludes that e-cigarettes are a gateway to smoking among youth. Evidence like this is the death knell to vaping, as perhaps it should be if it were true.

The problem, however, is that as I explained, the Pediatrics study cannot conclude that e-cigarettes are a gateway to smoking because it measured only e-cigarette experimentation at baseline and was unable to document that a single nonsmoking vaper actually became addicted to vaping. Nor was the study able to document that a single nonsmoking vaper actually used a product that contained nicotine. Since the Monitoring the Future study suggested that a solid majority of youth e-cigarette users do not use nicotine products, this is a major study limitation.

In fact, the overwhelming evidence suggests that e-cigarettes are actually contributing towards the denormalization of smoking. The magnitude of the gateway "risk" identified in the Pediatrics paper is mathematically impossible given the recent data showing that while e-cigarette experimentation has skyrocketed among youth, smoking rates among those same youths has plummeted. Furthermore, there is now direct evidence - this time from qualitative interviews with youth - that e-cigarettes may actually be a roadblock to smoking.

Today, I reveal that what makes the Pediatrics paper even more problematic than simply its unsupported conclusions is the fact that these conclusions have the appearance of being influenced by financial conflicts of interest among one of the study authors -- conflicts that the author hid from the public.

The Rest of the Story

Clearly, there is a strong financial interest in e-cigarette research among pharmaceutical companies that manufacture smoking cessation drugs. E-cigarettes and vaping products represent enormous potential competition to the sales of cessation drugs if they prove to be effective and of reasonable risk, which would lead to more lenient regulation.

One of these companies with a financial interest in e-cigarette research is GlaxoSmithKline, maker of the following cessation drugs: nicotine gum, nicotine lozenges, nicotine patches, Wellbutrin, and Zyban. Therefore, any of the Pediatrics study authors who has received money or research funding from GlaxoSmithKline has a significant financial conflict of interest that must be disclosed in the article.

Another company with a financial interest in e-cigarette research is Pfizer, which manufactures Chantix (varenicline), a very popular and lucrative smoking cessation drug. Therefore, any of the Pediatrics study authors who has received
money or research funding from Pfizer has a significant
financial conflict of interest that must be disclosed in the article.

However, all of the authors have signed a disclosure indicating that none of them have any financial conflict of interest: the disclosure statement reads "The authors have indicated they have no financial relationships relevant to this article to disclose."

Therefore, I would take this as meaning that none of the authors have had any financial relationships, such as receiving grant funding or consultant fees, from GlaxoSmithKline, Pfizer, or any other pharmaceutical companies that market smoking cessation medications.

Hiding a Conflict of Interest - the Rest of the Story

Unfortunately, this is not the case.

One of the study authors - Dr. Jonathan Samet - was actually named in a 2011 conflict of interest lawsuit filed by Lorillard and R.J. Reynolds against the FDA, which argued that: "During the last decade, Dr. Samet has received grant support for
research and writing from GSK on at least six occasions, including in
2010. In addition, he formerly led the Institute for Global Tobacco
Control, which is funded by GSK and Pfizer. Moreover, until 2009, Dr.
Samet received regular honoraria from Pfizer for his service on the
Pfizer Global Tobacco Advisory Board."

Dr. Samet has in fact acknowledged having received grant funding from GlaxoSmithKline. In addition, the organization that he directed - the Institute for Global Tobacco Control - was funded by GlaxoSmithKline and Pfizer. Furthermore, Dr. Samet agreed "to serve on Pfizer's global tobacco control advisory board and will be compensated." Dr. Samet acknowledged serving on Pfizer's tobacco control advisory board from 2004-2009.

The journal Pediatrics adheres to ICJME policies, and under those policies, authors are required to disclose all "relationships or
activities that readers could perceive to have influenced, or that give
the appearance of potentially influencing, what you wrote in the
submitted work." This requirement does not specify that the
relationships or activities must be current or within the past 3 years.
There is no time frame given, so the clear intent here is to make sure
that authors disclose any prior history of funding from corporations
that could give the appearance of a potential conflict.

To remind readers, a conflict of interest does not represent wrongdoing, and it is
actually in the authors' best interest to err on the side of being most
inclusive. After all, conflict of interest procedures are largely in
place to protect the author and the institution, not just the journal
and the readers. Conflict of interest disclosures are not some sort of
punitive procedure, forcing authors to pay penance for past wrongdoing.
There is no wrongdoing. The sole purpose is to make sure that any
financial relationships (no matter when they occurred) that could be perceived as potentially representing a conflict are disclosed.

In large part, the reason why virtually all scientific journals have
conflict of interest policies now is this past history of failed
disclosures of scientists' ties to the tobacco companies.

It is for this reason that it becomes so imperative for us, as
scientists in the tobacco control movement, to disclose our own
conflicts of interest. It would seem highly hypocritical for us to
demand that past relationships with tobacco companies need to be
disclosed but that past relationships with pharmaceutical companies can
remain hidden. No one is suggesting that the public health implications
are the same; however, the principle is.

Ultimately, if we want the public to take seriously our efforts to
protect the integrity of science from influence by corporations which
have a vested interest in influencing the public's opinion about the
safety of their products, then it becomes critical that we set the
example by being transparent about our own conflicts of interest.

Wednesday, June 15, 2016

In a letter to the editor published last week in the Bradenton Herald, an individual identified as being with the American Cancer Society Cancer Action Network tells the public that the Bishop-Cole amendment would "strip FDA's authority to review new products, ones becoming increasingly popular with youth, like e-cigarettes, cigars and hookah." She goes on to urge Florida's Senator Nelson not to "fall for the industry's latest trick to avoid critical FDA oversight of these addictive and potentially lethal products."

The Rest of the Story
There's just one problem with this letter. It's not telling the truth. The rest of the story is that in contrast to what the American Cancer Society-affiliated author states, the Bishop-Cole amendment would not strip FDA's authority to review new products. In fact, under the Bishop-Cole amendment, any new product placed on the market from the effective date of the deeming regulations on would need to obtain pre-market approval from the FDA before being sold. And that would involve a burdensome and expensive process, costing millions of dollars, and would virtually ensure that very few new vaping products reach the market.

This would damage the public's health because the newer vaping products are generally safer and more effective than the older ones. Moreover, it's only by allowing new products and improved products onto the market that we can improve the safety of e-cigarettes and definitively address problems such as exploding batteries, high levels of carbonyl compounds in some products, and other manufacturing and quality control problems.

So the problem is exactly the opposite of what the American Cancer Society is suggesting. The problem is not that the Bishop-Cole amendment takes away FDA's authority to review new products before they enter the market; the problem is that the amendment retains authority to require these ridiculous pre-market approval applications which stifle innovation and freeze existing defective products on the market so that they cannot make safety improvements.

Regardless of anyone's opinion about the way the FDA should regulate e-cigarettes, it is inappropriate to mislead the public by lying about the legislation that Congress is considering. The amendment being debated would absolutely not strip the FDA's authority to review new products. It would merely allow existing products to remain on the market. New products would still be subject to FDA review and pre-approval.

To be sure, I do not blame the author for this factual error. I'm sure she is getting her information from the American Cancer Society and they are the source of this lie.

In fact, we know that this is the case.

How?

Because with a little research, I uncovered the fact that this letter to the editor is part of a broader letter-writing campaign orchestrated by the American Cancer Society in which they told their volunteers exactly what to say, even though it was false information.

Consider this letter in the Tallahassee Democrat, also published last week, from another individual with the American Cancer Society Cancer Action Network. The letter is nearly identical in structure to the Bradenton letter, with just minor wording changes, suggesting that these ACS volunteers received a template that they were instructed to follow. The Tallahassee letter contains nearly the exact same lie, claiming that the Bishop-Cole amendment: "would strip FDA’s authority to review new products, many – like e-cigarettes – that are popular with kids."

But it doesn't stop there.

A nearly identical letter from another American Cancer Society volunteer from Avon Park, Florida appeared last week in the Highlands Today/Tampa Bay Times. And the letter contains the same lie that the ACS wants to spread far and wide: "The tobacco industry and its allies in Congress are working to attach
amendments to the agriculture appropriations bill that would fund the
FDA — that would strip FDA’s authority to review new products, ones
becoming increasingly popular with youth like e-cigarettes, cigars and
hookah."

In fact, this letter is almost identical to that in the Bradenton Herald, with just some minor word changes here and there.

This coordinated campaign of deception is not restricted to Florida. A nearly identical letter to the editor also appeared last week in the St. Louis Post-Dispatch. The letter is the same, word-for-word, as the Bradenton letter, except that it substitutes the number of tobacco-related deaths in Missouri for the number of deaths in Florida. It also claims that the Bishop-Cole amendment would: "strip FDA’s authority to review new products, ones becoming increasingly
popular with youth like e-cigarettes, cigars and hookahs."

Hopefully, the newspapers will not become aware of the fraud behind these letters because it is clear that the letters were not authentic. They were not written by the individuals who claimed to write them, but instead, were plagiarized from text that was presumably provided by the American Cancer Society Cancer Action Network.

While a pre-formatted letter is not inappropriate for a letter-writing campaign directed at individual policy makers, when you write a letter to the editor of a newspaper it is published with the understanding that the individual who signed the letter wrote the letter. So not only did the American Cancer Society err by orchestrating this campaign of deception, but it used its own volunteers as pawns to carry out the dissemination of the lie, and it put these volunteers in the unfortunate position of essentially being guilty of plagiarism, since they did not write the letters that are published under their names.

I also doubt that the American Cancer Society explained the truth to these individuals: that the Bishop-Cole amendment preserves the FDA's authority to review all new tobacco products, including e-cigarettes. This is a highly shady activity: essentially a conspiracy to de-fraud these newspapers and the public by making it look like tons of individuals independently came to the same conclusions about the Bishop-Cole amendment and wrote similar letters. The truth is that the letters were plagiarized and not in fact written by the authors to whom they are attributed. Shame on the American Cancer Society for using these volunteers in this way.

I guess I should answer my own question. Why must the American Cancer Society lie to the public? Because if they tell the truth, the public won't support their position. There would be no need to resort to lying if the ACS' argument stood on solid ground. The only reason to lie is if you can't win the argument by telling the truth. It's one thing for the American Cancer Society to take responsibility for its own lies. But to drag innocent volunteers into this and have them do the dirty work is unethical and unfair.

These volunteers working for the American Cancer Society are true heroes. They are dedicating their lives to this vital cause and volunteering their precious time to try to find ways to prevent and better treat cancer and to support cancer patients and cancer survivors. This is no way for them to be treated.

Monday, June 13, 2016

A new study published online today in the journal Pediatrics purports to show that electronic cigarettes are a gateway to smoking among youth. The study followed a sample of approximately 150 never-users of e-cigarettes and 150 ever users of e-cigarettes for one year. Both groups consisted entirely of never smokers. At one-year follow-up, the initiation of smoking was compared between the two groups. E-cigarette users were found to be six times more likely to have initiated smoking. Based on these findings, the paper concludes that e-cigarette use among youth increases the risk of progression to smoking: "These findings suggest that e-cigarette use may promote smoking during the transition to adulthood ... ."

This
study is virtually meaningless in terms of its evaluation of the
“gateway” hypothesis.

Baseline e-cigarette use was defined as ever
having taken
even one puff of an e-cigarette. And smoking initiation was similarly
defined as ever having taken even one puff of a cigarette. So the study
did not document that even one subject in the study was ever a regular
vaper. It is entirely possible (and in fact
likely) that the majority of these kids had experimented with
e-cigarettes, failed to become vapers, and then turned to regular
cigarettes. In fact, it’s entirely possible that had these kids been
able to stick with vaping, they would never have become smokers.

In addition, the study counted anyone who had even puffed a cigarette
as being a smoker. So theoretically, a subject could have had a single
puff of an e-cigarette and hated it, and then had a single puff of a
cigarette and hated it, and they would be considered
someone who initiated smoking because of first becoming addicted to
vaping.

What
the study does show, quite convincingly, is that kids who have a
personality type that lends itself to experimenting with e-cigarettes
are also
more likely to experiment with regular cigarettes. There is no surprise
here and had the researchers found anything different, one would have
to question the validity of the study findings. Frankly, the study
doesn’t really add any knowledge that we didn’t
have already. It simply confirms what we already knew: kids who are
more likely to experiment with e-cigarettes are more likely to
experiment with tobacco cigarettes.

In fact, what this study is basically documenting is that having ever
tried an e-cigarette is a better indicator of susceptibility to smoking
than the traditional measures of smoking susceptibility. That’s really
all one can conclude
from the study. The key point is that the e-cigarette group consisted
of youth who had ever puffed on an e-cigarette, not youth who reported
being regular vapers. In order for the gateway hypothesis to be true,
kids would have to become regular vapers – addicted
to nicotine – and then move on to smoking. The paper provides no
evidence that this is the case.

The rest of the story is that despite the way the results are being interpreted, the truth is that the study provides absolutely no evidence that electronic cigarettes are a gateway to smoking or that the use of vaping products increases rates of smoking initiation among youth. What the study demonstrates is merely that youth who experiment with e-cigarettes are more likely to experiment with cigarettes as well.

It is important to recognize that an equally plausible (and I think more likely) explanation of the results is that the ever e-cigarette using youth who progressed to smoking did so because they failed to take up vaping, rather than because they experimented with e-cigarettes. Had they become regular vapers, it is much less likely that they would have progressed to real smoking because after getting used to the sweet and tasty flavors of e-cigarettes, it is implausible that they would then become attracted to the harsh taste of real tobacco smoke.

Either way, the findings from this study do not provide any evidence to support the gateway hypothesis.

However, population-based data on trends in youth vaping and smoking released last week do provide evidence that relates to the gateway hypothesis. But those data suggest that e-cigarettes are a gateway away from smoking. In other words, as vaping has become more popular among youth, it has displaced cigarette smoking and contributed towards the de-normalization of cigarette smoking.

In fact, the strongest argument against the paper's interpretation of its findings is their inconsistency with the population-based data. If youth who experiment with e-cigarettes really were six times more likely to initiate smoking, then given the high level of experimentation, the observed rate of youth smoking would certainly be substantially higher than revealed by the Youth Risk Behavior Survey. Youth smoking rates would not have experienced a 41% decline concomitant with a 24-times increase in e-cigarette experimentation if e-cigarette use were really a substantial promoter of smoking initiation.

Thursday, June 09, 2016

The Centers for Disease Control and Prevention (CDC) yesterday released new data from the Youth Risk Behavior Survey (YRBS) revealing that despite a striking increase in youth e-cigarette use in the past two years, the prevalence of current smoking among high school students nationally declined by a whopping 31% from 2013 to 2015, falling from 15.7% to 10.8%. This represents a historic low and a 41% decline since 2011. Frequent smoking also fell to a historic low, dropping from 5.6% to 3.4%, a 39% decline. Daily smoking dropped by 42%, from 4.0% to 2.3%, and overall tobacco use declined by 23%, falling from 24.0% to 18.5%.

The 41% drop in youth smoking from 2011 to 2015 occurred at the same time as a 24-fold increase in youth e-cigarette use, which rose from just 1% to 24%.

In response to these data, and in spite of the data, anti-smoking advocates and groups claimed that this shows e-cigarettes are leading kids to smoking.

For example, according to a Health Dayarticle: "Dr. Len Horovitz, a pulmonary specialist at Lenox Hill Hospital in New
York City, said, 'While cigarette smoking in high school students is at
an all-time low, the rise of e-cigarette use poses a risk that teenagers
will transition from 'e' to 'real' cigarettes.'"

The Campaign for Tobacco-Free Kids claimed that: "this survey also raises fresh concerns that other tobacco products,
especially electronic cigarettes and cigars, are undermining overall
efforts to reduce youth tobacco use and could be luring a new generation
of kids into nicotine addiction."

The Rest of the Story

For the first time in a long time, I have to admit that the anti-smoking groups are correct about electronic cigarettes: these products are indeed a gateway.

They are a gateway away from smoking.

It is increasingly becoming clear that the advent of vaping has contributed to the most marked decline in youth smoking in recent history. In contrast to what the anti-smoking groups are saying, overall tobacco use is falling, not staying the same, and the use of e-cigarettes is not undermining progress in reducing youth smoking but contributing to it.

There are simply too many youth using e-cigarettes to argue that vaping is not to some extent replacing smoking as a behavior in the youth population.

Moreover, it is now abundantly clear that e-cigarettes are not serving as a gateway to smoking and tobacco use. In contrast, vaping appears to be acting as a deterrent, or more accurately, as a diversion away from smoking. In other words, it appears that as an alternative to smoking, electronic cigarettes are diverting kids from smoking to vaping.

Obviously, reducing smoking by diverting youth to an alternate form of nicotine use is not an ideal solution to the problem of youth tobacco use and smoking addiction. It would be preferable to reduce smoking without having youth turn to any other behavior that carries some risk. Nevertheless, the rest of the story is that e-cigarettes are not undermining efforts to reduce youth smoking and/or youth tobacco use. They are actually contributing to those efforts.

To be clear, this does not mean that we should be encouraging vaping among youth. However, it does mean that the widespread concern that e-cigarettes will be a gateway to smoking is just not panning out. Vaping is clearly not resulting in the re-normalization of smoking. It is quite the opposite. Vaping is helping to further de-normalize smoking. Vaping is becoming increasingly cool among youth and helping to make smoking ever more unpopular and uncool. What is playing out is exactly the opposite of what anti-smoking groups claim.

There is no question that the FDA's recent ban on sale of e-cigarettes to minors is warranted, as are restrictions on marketing of e-cigarettes to youth and educational campaigns to help youth understand the health risks of both smoking and vaping. But we also need to be careful. The last thing we want to do at this stage of the game is to create an increased demand for real cigarettes by removing the competition. Banning e-cigarette flavors would do just that, as would allowing the predicate date in the current e-cigarette regulations to remain.

What this story also reveals is that anti-smoking groups have a pre-scripted message and that they automatically twist their interpretation of scientific data to facilitate that message, rather than allowing the science to inform their communications and their agenda. This is a striking example because the data are so inconsistent with the anti-smoking groups' conclusions that it is almost comical to see.

Indeed, as youth e-cigarette use increased from 1% to 24% concurrently with a massive 41% decline in youth smoking, anti-smoking groups are concluding that vaping is re-normalizing smoking. If that's the case, then I guess we should strive to re-normalize smoking as much as we can.

Sunday, June 05, 2016

Readers of the Rest of the Story may have noticed that I have not posted for a few days. This is not for lack of material. Lots is happening that deserves comment, and in the days to follow I will catch readers up on some important developments, including two more lawsuits filed against the FDA in an attempt to overturn its electronic cigarette deeming regulations.

I have not been able to write because I have been too distraught. I have come to the realization that the anti-smoking movement - which I have been a part of for the past 31 years, is essentially dead. And even worse, the anti-smoking movement is now actively promoting smoking. This is extremely difficult for me to understand and to reconcile. And it is especially difficult to stomach given the irony that while the anti-smoking movement is promoting smoking, hundreds of for-profit companies are the ones who are actually fighting to make smoking obsolete. In contrast, anti-smoking groups are fighting to preserve smoking and make sure that it does not become obsolete.

The last straw - the straw that broke the camel's back - is the anti-smoking movement's support of a complete ban on flavored e-liquids for use in vaping products, which follows its earlier vigorous opposition to a complete ban on flavors in toxic tobacco cigarettes.

To be clear, the major anti-smoking groups - including the Campaign for Tobacco-Free Kids, American Cancer Society, American Heart Association, and American Lung Association - opposed a complete ban on flavored tobacco cigarettes, but are now supporting a complete ban on flavored tobacco-free cigarettes. In other words, these groups have lobbied to retain the tobacco companies' ability to attract kids to smoking using a tasty, smooth, and attractive flavoring, while lobbying to remove non-tobacco companies' ability to attract smokers away from cigarettes and toward a much safer tobacco-free, smoke-free alternative.

Last week, it was revealed that the Office of Management and Budget (OMB) had made one critical change in the deeming regulations sent to it for review by the FDA. Specifically, the OMB removed from the regulations a ban on the use of all flavors except tobacco in e-liquids. This action is in accordance with the recommendation that I made to OMB in my meeting with OIRA staff last year.

After this revelation, the major anti-smoking groups and advocates criticized OMB, indicating that these groups support a complete ban on flavored e-cigarettes. For example, the American Lung Association stated: "We are deeply troubled that these important
safeguards were stripped in this way when FDA repeatedly demonstrated
that the science shows flavored products appeal to youth and young
adults."

The Campaign for Tobacco-Free Kids stated: "It is deeply disappointing that the White House missed this opportunity
to protect our nation’s children by deleting this provision to remove
candy- and fruit-flavored e-cigarettes and cigars from the market."Dr. Stan Glantz argued that the FDA should issue a rule that bans all flavored e-cigarettes immediately.The Rest of the StoryThere is no greater action that the FDA could take to promote cigarette smoking than to ban the use of flavors in e-cigarettes. And by supporting such a ban, the anti-smoking groups are essentially promoting cigarette smoking in the population.Flavored e-cigarettes have helped literally hundreds of thousands of smokers to quit smoking and millions more to cut down substantially on the amount that they smoke. A ban on flavored e-cigarettes would have resulted in countless former smokers being forced to return to smoking and countless current smokers being unable to quit smoking due to their lack of interest in switching to a non-flavored or tobacco-flavored alternative product.Without question, the most critical feature that makes electronic cigarettes attractive to adult smokers and allows them to compete with deadly tobacco cigarettes is that they offer a broad array of flavors, providing ample choice so that every smoker can find a flavor that is particularly attractive. Without flavors in e-liquids, vaping would lose most of its appeal for most of its users and would largely wither away. Jacob Sullum has pointed out that 77% of vapers prefer flavored products. To be sure, a ban on flavored e-cigarettes would have amounted to a de facto ban on all e-cigarettes and would have caused tens of thousands of former smokers to return to cigarette smoking.

That supposedly anti-smoking groups are supporting a policy that is the single most effective step that the FDA could take to promote cigarette smoking in the United States is unfortunate, sad, and disillusioning. Clearly, the anti-smoking groups care more about kids (most of whom are already tobacco users) experimenting with flavored vaping products than with smokers dying of cancer, lung disease, heart disease, stroke, and peripheral vascular disease.

After pain-staking analysis, I have come to several conclusions about why anti-smoking groups are now ironically promoting smoking:1. Electronic cigarettes represent a huge threat to their ideology. There is simply no room for a nicotine-containing product that could actually help improve people's health.2. E-cigarettes are also a threat because it destroys the anti-smoking ideology to think that a person might actually derive some enjoyment from nicotine without it killing them.3. It is unacceptable for people to be using a nicotine product that does not kill them because it doesn't allow for punishment of what is seen as this bad moral choice. In contrast, continued high levels of smoking are tolerable because these nicotine addicts are being punished for their poor behavior.4. The "save the smoker" argument does not bring in donations, while the "save our children" appeal allows anti-smoking groups to continue to produce effective financial appeals to their constituents.5. E-cigarettes not only threaten to make smoking obsolete, but to greatly reduce the use of pharmaceutical products, harming companies with which numerous anti-smoking groups have significant financial relationships.6. Actually making smoking obsolete would essentially put anti-smoking groups out of business. Ensuring that vaping remains at the margins of society helps ensure that anti-smoking professionals continue to have jobs. Vaping products would actually make a cigarette "end-game" possible because they provide an alternative to smokers, easing concerns about the development of a cigarette black market. Thus, vaping actually does pose a threat to a continued high availability of jobs in tobacco control.Fortunately, the OMB listened to my advice (and similar advice from thousands of vapers, harm reduction scientists and advocates, e-cigarette distributors, retailers, manufacturers, and consumer advocacy groups, and even the tobacco companies) and decided that promoting cigarette smoking is not an appropriate action for a public health agency like the FDA to take. The former anti-smoking groups will continue to push for a ban on flavored e-cigarettes, and I will continue to everything in my power to oppose and prevent such a regulation from being promulgated and approved.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.